CN1742784A - Chinese medicine preparation of clearing heat and detoxifying and preparing method - Google Patents
Chinese medicine preparation of clearing heat and detoxifying and preparing method Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine preparation capable of clearing away heat and toxic material and its preparation method. Said preparation is mde up by using Chinese medicinal materials of scutellaria root, capejasmine and forsythia fruit through a certain preparation process.
Description
Technical field:
The present invention relates to Chinese medicine preparation of a kind of heat-clearing and toxic substances removing and preparation method thereof, said preparation is formed through extracting processing and preparing by baikal skullcap root, Fructus Gardeniae, Fructus Forsythiae.
Background technology:
Diseases such as common upper respiratory tract infection, influenza, acute bronchitis, cardinal symptom have hyperpyrexia, micro evil wind, watery nasal discharge, cough, laryngopharynx swelling and pain, floating pulse etc.According to statistics, because the death that heating causes, the whole world has at least more than 2,000,000 every year, and especially upper respiratory tract infection and influenza cause hyperpyrexia, have a strong impact on the healthy of people, and the expense that is used for the treatment of every year is up to tens yuan.
The reason that causes hyperpyrexia has many, and doctor trained in Western medicine mainly is to use antipyretic analgesic to the treatment of heating, the antiviral antibacterials, though it is brought down a fever soon, side effect is big, mainly shows as gastrointestinal reaction such as nausea,vomiting,diarrhea, stomachache and to hematoblastic influence.The traditional Chinese medical science is principle according to the characteristics of wind heat exterior syndrome with heat-clearing and toxic substances removing, dispelling wind to relieve the exterior syndrome, has formed many eutherapeutic dosage forms, but also has certain limitation.The present invention derives from hospital experience usefulness side, has passed through the clinical verification of more than ten years.Effect with heat-clearing and toxic substances removing, dispelling wind to relieve the exterior syndrome is used for the heating disease due to the affection due to external wind and heat, has the characteristics fast, antibiotic, that antivirus action is strong of bringing down a fever.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation, said preparation is prepared from baikal skullcap root, Fructus Gardeniae, Fructus Forsythiae, and said preparation is made by following Chinese medicinal raw materials.
Its set of dispense than (weight portion) in crude drug,
1000～6000 parts of Radix Scutellariaes, Fructus Gardeniae 750-3000 part, Fructus Forsythiae 750-3000 part.
Preferably 2000～4000 parts of Radix Scutellariaes, Fructus Gardeniae 1000-2000 part, Fructus Forsythiae 1000-2000 part.
More preferably 3000 parts of Radix Scutellariaes, 1500 parts of Fructus Gardeniaes, 1500 parts of Fructus Forsythiaes.
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000g, oral liquid 1000ml etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutically active substance in the pharmaceutical preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every of injection etc., in the unit dose, the amount that contains active substance is 5-800mg, preferably 20-500mg.
Pharmaceutical preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation, controlled release preparation.
Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention, active component can extract three flavor medicines respectively, and extraction also can mix.When extracting respectively, method is as follows:
Radix Scutellariae extracts baicalin: get Radix Scutellariae extracting in water secondary, merge secondary raffinate, filter, add hydrochloric acid and transfer pH value to 1.0～2.0, left standstill 24 hours, precipitation adds 8 times of water gagings, stirs, and transfers PH to 7.0 with sodium hydroxide solution, and add ethanol and make its dissolving, to filter, filtrate is transferred pH value to 2.0 with acid, leaves standstill, get precipitation, precipitation adds the aqueous alkali dissolving, adds 0.5% active carbon, fully stir, and 50 ℃ of insulations 30 minutes, add acid and transfer pH value 2.0, filter, get precipitation and add washing with alcohol, get baicalin.
Fructus Forsythiae, Fructus Gardeniae decoct with water secondary, extracting liquid filtering, and filtrate is crossed macroporous resin adsorption, eluting is resolved, and reclaims ethanol to there not being the alcohol flavor, add 3～4 times of water gagings, transfer PH to 7.0, being concentrated into relative density is 1.15, puts cold rnning and goes into ethanol and make and contain the alcohol amount and reach 85%, left standstill 12 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor, and is standby.
More than three kinds of active component mix, as active constituents of medicine, add the medicine acceptable carrier after, make pharmaceutical preparation by the galenic pharmacy routine techniques.
Below experiment is used to illustrate beneficial effect of the present invention:
Chinese medicine preparation of the present invention can suppress influenza virus, respiratory syncytial virus, adenovirus type, Coxsackie virus, herpesvirus and duplicate intracellular; Bacillus pyocyaneus, staphylococcus aureus, Staphylococcus citreus, beta hemolytic streptococcus, streptococcus pneumoniae, Bacillus proteus, Bacillus typhi and white grapes bacterium there is stronger inhibitory action; Inflammatory swelling there is the obvious suppression effect, has tangible refrigeration function simultaneously.
The present invention has the effect of heat-clearing and toxic substances removing, dispelling wind to relieve the exterior syndrome, is applicable to bacillary and viral diseases such as heating that wind heat causes, upper respiratory tract infection, tonsillitis, pharyngitis, viral pneumonia, viral enteritis, bacterial enteritis, viral conjunctivitis, viral keratitis.Have the characteristics fast, antibiotic, that antivirus action is strong of bringing down a fever.
One, pharmacological research data
1, pharmacodynamic study
The antivirus test result: observe the effect of this injection anti respiratory syncytial virus with cell tissue liquid culture method, the result shows that this product has the obvious suppression effect to syncytial virus.
Resisiting influenza virus experiment: observe the effect of this injection resisiting influenza virus with the Embryo Gallus domesticus method, the experimental result of three concentration (10,100,1000 times) shows that this product has than the obvious suppression effect influenza virus.
The bacteriostatic experiment result: this injection has tangible bacteriostasis to Diplococcus pneumoniae, staphylococcus aureus, streptococcus, paratyphoid bacillus A, sonne bacillus, than the high dilution factor of the antibacterial intensity of SHUANGHUANGLIAN ZHUSHEYE; To Bacillus typhi, shigella flexneri, this injection is consistent with the antibacterial intensity of SHUANGHUANGLIAN ZHUSHEYE.
The antiphlogistic effects experiment: this injection has regressive effect through gastric infusion to inflammatory congestion.Inject administration through gastric infusion, through the abdominal cavity antiinflammatory effect is all arranged.
2, toxicologic study
The ICR mouse stomach gives granule of the present invention, fails to measure half lethal dose, no overt toxicity reflection, and maximum dosage is 72g/kg, is equivalent to crude drug 258g/kg, is 360 times of the clinical consumption of people.The long term toxicity test result also shows and has no adverse reaction and avirulence.It is safe using this product.
In sum, this injection has the effect of remarkable inhibition virus and antibacterial, and toxicity is very little, and injection safety is for treating the Chinese medicine of bacillary and viral disease such as heating that wind heat causes, upper respiratory tract infection, tonsillitis, pharyngitis, viral pneumonia preferably.
Two, clinical research data
Observe the therapeutical effect of this injection to infant upper respiratory tract infection.The patient is divided into treatment group 208 example and matched group (SHUANGHUANGLIAN ZHUSHEYE) 68 examples, the course of treatment of observing recovery from illness case before and after the treatment relatively, heating case body temperature reduce to normal time relatively, two groups of cardinal symptoms and sign disappearance situation compare.Controlled trial the results are shown in following table:
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate |
| Treatment group matched group | 213 71 | 142(66.7) 31(43.7) | 54(25.4) 24(33.8) | 15(7.0) 11(15.5) | 2(0.9) 5(7.0) | 211(99.1) 66(93.0) |
The analysis showed that χ by statistics
2=18.22, there is the difference of highly significant P＜0.001 between the curative effect of i.e. treatment group and the SHUANGHUANGLIAN ZHUSHEYE group.
The course of treatment of recovery from illness case is relatively: treatment group 142 examples of fully recovering, and average course of treatment is (51.23 ± 10.67) h; Contrast gives recovery from illness 31 examples, and average course of treatment is (56.45 ± 12.30) h.Be short with the treatment group course of treatment of two groups of recovery from illness cases, shows through the t check, compares with the SHUANGHUANGLIAN ZHUSHEYE group, and difference has significance t=2.40, P＜0.05.
Heating case body temperature is reduced to normal time relatively: treatment group body temperature is reduced to normal 121 examples, and body temperature is reduced to and normally is (29.37 ± 13.23) h in a twinkling; SHUANGHUANGLIAN ZHUSHEYE body temperature drops to normal 42 examples, and it is (38.55 ± 12.36) h that body temperature is reduced to normal time, and it is short than SHUANGHUANGLIAN ZHUSHEYE that treatment group body temperature is reduced to normal time, and through the t check, two groups of differences have significance meaning t=3.93, P＜0.01.
The clinical research summary
Confirm through clinical trial, Chinese medicine preparation of the present invention has the effect of heat-clearing and toxic substances removing, dispelling wind to relieve the exterior syndrome, is applicable to bacillary and viral diseases such as heating that wind heat causes, upper respiratory tract infection, tonsillitis, pharyngitis, viral pneumonia, viral enteritis, bacterial enteritis, viral conjunctivitis, viral keratitis.Have the characteristics fast, antibiotic, that antivirus action is strong of bringing down a fever.
Chinese medicine preparation treatment group total effective rate 99.1% of the present invention, cure rate 66.7%; Matched group total effective rate 93%, cure rate 43.7%, treatment group and matched group relatively have significant difference.A kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease of the present invention is injection, granule, drop pill.
Concrete true mode:
Specific embodiment is as follows, includes but not limited to the following example.
Embodiment 1
The preparation method of injection active component is as follows:
Radix Scutellariae extracts baicalin: get Radix Scutellariae 3000g, the extracting in water secondary merges secondary raffinate, filters, add hydrochloric acid and transfer pH value to 1.0～2.0, left standstill 24 hours, precipitation adds 8 times of water gagings, stirs, transfer PH to 7.0 with sodium hydroxide solution, and add ethanol and make its dissolving, filter, filtrate is transferred pH value to 2.0 with acid, leave standstill, get precipitation, precipitation adds the aqueous alkali dissolving, adds 0.5% active carbon, fully stir, and 50 ℃ of insulations 30 minutes, add acid and transfer pH value 2.0, filter, get precipitation and add washing with alcohol, get baicalin 65g.
Fructus Forsythiae, each 1500g of Fructus Gardeniae decoct with water secondary, extracting liquid filtering, filtrate is crossed macroporous resin adsorption, and eluting is resolved, reclaim ethanol to there not being the alcohol flavor, add 3～4 times of water gagings, transfer PH to 7.0, being concentrated into relative density is 1.15, put cold rnning and go into ethanol and make and contain alcohol amount and reach 85%, left standstill the leaching supernatant 12 hours, reclaim ethanol to there not being the alcohol flavor, standby.
Get the baicalin extract, it is an amount of to add water, and heating also transfers PH to 7.0 to make dissolving with sodium hydroxide, adds Fructus Forsythiae, gardenia extract, standardize solution adds 0.5% active carbon, keeps little the boiling 15 minutes of pH value 7.0 heating, filters, bottling, lyophilization promptly gets 1000 bottles (250mg/ bottles).
Embodiment 2
Granule
It is characterized in that the preparation method of active component, specific as follows:
Radix Scutellariae extracts baicalin: get Radix Scutellariae 3000g, the extracting in water secondary merges secondary raffinate, filters, add hydrochloric acid and transfer pH value to 1.0～2.0, left standstill 24 hours, precipitation adds 8 times of water gagings, stirs, transfer PH to 7.0 with sodium hydroxide solution, and add ethanol and make its dissolving, filter, filtrate is transferred pH value to 2.0 with acid, leave standstill, get precipitation, precipitation adds the aqueous alkali dissolving, adds 0.5% active carbon, fully stir, and 50 ℃ of insulations 30 minutes, add acid and transfer pH value 2.0, filter, get precipitation and add washing with alcohol, get baicalin 68g.
Fructus Forsythiae, each 1500g of Fructus Gardeniae decoct with water secondary, extracting liquid filtering, filtrate is crossed macroporous resin adsorption, and eluting is resolved, reclaim ethanol to there not being the alcohol flavor, add 3～4 times of water gagings, transfer PH to 7.0, being concentrated into relative density is 1.15, putting cold rnning goes into ethanol and makes and contain alcohol amount and reach 85%, left standstill 12 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor.The drying 185g that gets dry extract.
After getting above three kinds of active component pulverizing, mix homogeneously, add a certain amount of adjuvant mix homogeneously, make soft material in right amount with ethanol, the system granule, cold drying, granulate gets granule 1000g, is distributed into bag (a 1g/ bag).
Claims (9)
1, a kind of Chinese medicine preparation of heat-clearing and toxic substances removing is characterized in that per 1000 dosage units are made 1000～6000 parts of Radix Scutellariaes, Fructus Gardeniae 750-3000 part, Fructus Forsythiae 750-3000 part by following Chinese medicinal raw materials.
2, the Chinese medicine preparation of claim 1 is characterized in that per 1000 dosage units are made 2000～4000 parts of Radix Scutellariaes, Fructus Gardeniae 1000-2000 part, Fructus Forsythiae 1000-2000 part by following Chinese medicinal raw materials.。
3, the Chinese medicine preparation of claim 1 is characterized in that per 1000 dosage units are made by following Chinese medicinal raw materials, 3000 parts, 1500 parts of Fructus Gardeniaes, 1500 parts of Fructus Forsythiaes.
4, the Chinese medicine preparation of claim 1-2 is to be fit to medicinal various dosage forms.
5, the Chinese medicine preparation of claim 4 is injection or capsule.
6, the Chinese medicine preparation of claim 1 wherein also comprises the medicine acceptable carrier.
7, the application of the Chinese medicine preparation of claim 1 in preparation heat-clearing and toxic substances removing medicine.
8, the preparation method of the Chinese medicine preparation of claim 1 is characterized in that, the process following steps:
Radix Scutellariae extracts baicalin: get Radix Scutellariae extracting in water secondary, merge secondary raffinate, filter, add hydrochloric acid and transfer pH value to 1.0～2.0, left standstill 24 hours, precipitation adds 8 times of water gagings, stirs, and transfers PH to 7.0 with sodium hydroxide solution, and add ethanol and make its dissolving, to filter, filtrate is transferred pH value to 2.0 with acid, leaves standstill, get precipitation, precipitation adds the aqueous alkali dissolving, adds 0.5% active carbon, fully stir, and 50 ℃ of insulations 30 minutes, add acid and transfer pH value 2.0, filter, get precipitation and add washing with alcohol, get baicalin;
Fructus Forsythiae, Fructus Gardeniae decoct with water secondary, extracting liquid filtering, and filtrate is crossed macroporous resin adsorption, eluting is resolved, and reclaims ethanol to there not being the alcohol flavor, add 3～4 times of water gagings, transfer PH to 7.0, being concentrated into relative density is 1.15, puts cold rnning and goes into ethanol and make and contain the alcohol amount and reach 85%, left standstill 12 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor, and is standby;
Above active component mixes, as active constituents of medicine.
9, preparation method according to Claim 8 is characterized in that the pharmaceutically active substance that the method for claim 8 obtains, and presses pharmaceutical dosage form and adds adjuvant, makes preparation with the galenic pharmacy routine techniques.
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| CN 200410073608 CN1742784A (en) | 2004-08-30 | 2004-08-30 | Chinese medicine preparation of clearing heat and detoxifying and preparing method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109432287A (en) * | 2018-12-21 | 2019-03-08 | 济南亿民动物药业有限公司 | A kind of traditional Chinese medicine oral liquid and preparation method thereof of prevention and treatment poultry excessive heat in the system card |
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2004
- 2004-08-30 CN CN 200410073608 patent/CN1742784A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109432287A (en) * | 2018-12-21 | 2019-03-08 | 济南亿民动物药业有限公司 | A kind of traditional Chinese medicine oral liquid and preparation method thereof of prevention and treatment poultry excessive heat in the system card |
| CN109432287B (en) * | 2018-12-21 | 2021-06-04 | 济南亿民动物药业有限公司 | Traditional Chinese medicine oral liquid for preventing and treating excessive heat syndrome of poultry qi system and preparation method thereof |
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